CPRX - Catalyst comments on Health Canada decision to re-issue an NOC for Ruzurgi
Catalyst Pharmaceuticals (CPRX) comments on the recent decision by Health Canada to re-issue a Notice of Compliance ("NOC") for the company's rival drug Ruzurgi (amifampridine tablets), which is indicated to treat patients with Lambert-Eaton Myasthenic Syndrome ((LEMS)).The drug's original NOC was quashed in a recent federal court decision, which sent the matter back to Health Canada to re-determine its decision to grant marketing authority to Ruzurgi despite Firdapse's data protection rights under Canadian law, the company said.Catalyst and its Canadian sublicensee, KYE Pharmaceuticals ("KYE"), are currently evaluating their further litigation options to challenge Health Canada’s most recent decision.Shares down marginally after-market.
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Catalyst comments on Health Canada decision to re-issue an NOC for Ruzurgi